Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, Vildagliptin
Brief summary
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.
Interventions
DRUGVildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Inclusion criteria
* Completion of study CLAF237A2307 within 4 weeks of entering into the extension * Written informed consent * Ability to comply with all study requirements * Blood glucose criteria must be met
Exclusion criteria
* Premature discontinuation from study CLAF237A2307
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at 108 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event profile after 108 weeks of treatment | — |
| Change in HbA1c from week 52 to week 108 | — |
| Change from baseline in fasting plasma glucose at week 108 | — |
| Change in fasting plasma glucose from week 52 to week 108 | — |
| Change from baseline in body weight at week 108 | — |
Countries
Germany
Outcome results
None listed